NCT03252327

Brief Summary

Frequent pain and distress may affect infants' brain and neural development, and highlight the need for relieve pain interventions. Peripheral venous puncture procedures are an important source of preterm infants' pain and distress. Brain development is mainly created by infant sensory experience. It becomes important, therefore, to relieve preterm infants' pain and distress using multiple sensory integrations during peripheral venous puncture procedures.The proposed 2-year study has specific aim: to compare the effects of different combination of sensory integrations on preterm infants' pain and distress before, during, and after peripheral venous puncture procedures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

August 26, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

1.2 years

First QC Date

August 8, 2017

Last Update Submit

May 9, 2019

Conditions

Preterm InfantsPain

Outcome Measures

Primary Outcomes (1)

  • Preterm infants' pain

    Premature Infant Pain Profile-Revised (PIPP-R) for pain, A score \<7 suggests no or little pain, 7-12 mild to moderate pain and scores \>12 indicate moderate to severe pain.

    20-30 minutes (during peripheral venous puncture procedures)

Secondary Outcomes (5)

  • preterm infants' physiological parameters:heart rate

    20-30 minutes (during peripheral venous puncture procedures)

  • Preterm infants' physiological parameters:respiration rate

    20-30 minutes (during peripheral venous puncture procedures)

  • Preterm infants' physiological parameters: oxygen saturation

    20-30 minutes (during peripheral venous puncture procedures)

  • preterm infants' behavioral responses

    20-30 minutes (during peripheral venous puncture procedures)

  • preterm infants' duration of fussing and cry

    20-30 minutes (during peripheral venous puncture procedures)

Study Arms (4)

routine care

NO INTERVENTION

Preterm infants in the control condition will receive only usual neonatal intensive care units (NICU) care

Multiple Sensory Integrations(1)

EXPERIMENTAL

The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).

Other: Multiple Sensory Integrations

Multiple Sensory Integrations(2)

EXPERIMENTAL

The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).

Other: Multiple Sensory Integrations

Multiple Sensory Integrations(3)

EXPERIMENTAL

The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).

Other: Multiple Sensory Integrations

Interventions

Multiple Sensory IntegrationsOTHER

breast milk odor, oral expressed breast milk, heartbeat sounds, nonnutritive sucking.

Multiple Sensory Integrations(1)Multiple Sensory Integrations(2)Multiple Sensory Integrations(3)

Eligibility Criteria

Age3 Days - 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age (GA) 28-37 weeks
  • Post-menstrual age (PMA) 29-38 weeks
  • Postnatal age 3-28 days
  • Sable condition (NTISSscore ≦ 22)
  • Apgar scores≧7 at 5 minutes after birth

You may not qualify if:

  • Neurologic impairment
  • Congenital anomalies
  • Surgery
  • Severe growth restriction at birth
  • Severe medical conditions requiring treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 8, 2017

First Posted

August 17, 2017

Study Start

August 26, 2017

Primary Completion

November 1, 2018

Study Completion

November 30, 2018

Last Updated

May 13, 2019

Record last verified: 2019-05

Locations

TW(1)